Table 5.
Incidence of the most common treatment‐related adverse events.
Study I
| Adverse events | Sildenafil (n = 14) | Saquinavir Sildenafil/ saquinavir (n = 13) | Placebo/ saquinavir (n = 13) | Sildenafil (n = 14) | Placebo Sildenafil/ placebo (n = 14) | Placebo/ placebo (n = 14) |
|---|---|---|---|---|---|---|
| Total number of subjects with adverse events | 8 | 10 | 3 | 5 | 11 | 4 |
| Discontinued therapy due to adverse event | 0 | 0 | 0 | 0 | 0 | 0 |
| Headache | 4 | 7 | 3 | 1 | 7 | 2 |
| Vasodilation | 3 | 1 | 0 | 2 | 2 | 0 |
| Diarrhoea | 0 | 1 | 0 | 0 | 0 | 0 |
| Nausea | 0 | 0 | 0 | 0 | 2 | 0 |
| Dyspepsia | 0 | 1 | 0 | 1 | 1 | 0 |
| Paresthesia | 0 | 1 | 0 | 1 | 0 | 0 |
| Dizziness | 1 | 3 | 0 | 2 | 2 | 0 |
| Rhinitis | 2 | 4 | 1 | 1 | 3 | 0 |
| Abnormal vision | 0 | 0 | 0 | 0 | 1 | 0 |
| Study I | ||||||
| Adverse events | Sildenafil (n = 14) | Ritonavir Sildenafil/ ritonavir (n = 14) | Placebo/ ritonavir (n = 14) | Sildenafil (n = 14) | Placebo Sildenafil/ placebo (n = 14) | Placebo/ placebo (n = 14) |
| Total number of subjects with adverse events | 9 | 12 | 11 | 11 | 8 | 2 |
| Discontinued therapy due to adverse event | 0 | 0 | 0 | 0 | 0 | 0 |
| Headache | 5 | 4 | 1 | 7 | 5 | 0 |
| Asthenia | 0 | 5 | 5 | 2 | 0 | 1 |
| Vasodilation | 6 | 6 | 1 | 3 | 4 | 1 |
| Postural hypotension | 0 | 3 | 0 | 0 | 2 | 0 |
| Diarrhoea | 0 | 3 | 2 | 0 | 0 | 0 |
| Nausea | 1 | 4 | 4 | 0 | 0 | 0 |
| Dyspepsia | 1 | 2 | 2 | 0 | 0 | 0 |
| Paresthesia | 0 | 4 | 5 | 0 | 0 | 0 |
| Dizziness | 0 | 3 | 1 | 0 | 1 | 0 |
| Rhinitis | 0 | 3 | 0 | 1 | 2 | 0 |
| Abnormal vision | 1 | 3 | 0 | 0 | 0 | 0 |